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Azithromycin for Wheezing in Preschoolers (AZ-SWED Trial)
AZ-SWED Trial Summary
This trial will compare the 5-day outcome of preschool children presenting to an Emergency Department (ED) with an acute, severe wheezing episode and treated with either once daily oral Azithromycin (12 mg/kg/day for 5 days) or placebo.
AZ-SWED Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowAZ-SWED Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.AZ-SWED Trial Design
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Who is running the clinical trial?
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- Your Pediatric Respiratory Assessment Measurement (PRAM) score was 4 or higher at any point during the emergency room visit.Criterion: You have a long-term illness or condition that could affect your ability to participate in the study, such as seizures, developmental delays, or chronic lung disease. You have certain heart problems, were born prematurely, or have a history of certain medical procedures. You have certain allergies, are currently involved in another medical study, or cannot speak English or Spanish.I am between 18 and 59 months old.I have taken antibiotics in the last 2 weeks.I have used steroids for wheezing in the last 2 weeks.I may have inhaled a foreign object in the last 2 weeks.A doctor or nurse heard wheezing when I breathed out during my ED visit.I am currently on antibiotics for an acute infection.
- Group 1: Treatment - Active
- Group 2: Treatment - Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the cap for participators in this clinical trial?
"Correct. The information hosted on clinicaltrials.gov verifies that this medicinal experiment, which was first posted on September 22nd 2021, is still actively recruiting participants across 6 sites for a total of 1476 patients."
Does Treatment - Active meet the regulatory standards set forth by the FDA?
"The team at Power rated the safety of Treatment - Active as a 3 due to prior clinical evidence supporting efficacy, in addition to multiple rounds of data demonstrating its safety."
Does the protocol for this experiment require participants to be over 25 years of age?
"For this clinical study, only patients falling within the 18-month to 5 year age range are eligible. 186 trials target children younger than 18 months while 392 studies focus on seniors above 65 years of age."
Is there a possibility for me to participate in this experiment?
"This medical study is seeking 1476 toddlers and children with asthma. The patient's age must be between 18 months old to 5 years of age, they need to have exhibited expiratory wheezing during their emergency department visit, and a Pediatric Respiratory Assessment Measurement score higher than or equal to 4 at any time during the ED stay."
Are there any vacancies left in this trial for participants?
"Data hosted on clinicaltrials.gov verify that this medical trial is actively looking for participants, having been originally published on September 22nd 2021 and updated most recently on November 30th 2022."
How many medical centers are currently hosting this clinical trial?
"Patients are being admitted to the Children's Hospital of New york Medical Center in Manhattan, Cincinnati Children's Hospital Medical Centre, and Boston Children's Hospital. Additionally, 6 more medical centres will be incorporated into this trial."
Has Treatment - Active been evaluated in any prior investigations?
"Presently, there are 55 active clinical trials investigating Treatment - Active. Of which 18 of these inquiries have advanced to Phase 3 testing. Though most studies are held in Albuquerque, New mexico, altogether 694 sites accommodate this treatment's research."
What medical conditions have been demonstrated to respond positively to Treatment - Active?
"Administration of Treatment - Active is a typical remedy for genital ulcer disease (GUD). Moreover, it can help treat chlamydia in adults and cervicitis."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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